Site Contract Specialist

JR Italy; Genova; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a skilled professional to join their Global Clinical Study Support Department. This role involves driving the tactical delivery of studies, negotiating contracts, and collaborating with project teams to ensure compliance with pharmaceutical standards. The ideal candidate will have extensive experience in client service within the biotech or pharmaceutical sectors, along with a strong educational background in business or healthcare. This is a fantastic opportunity to contribute to impactful clinical research while mentoring junior staff and enhancing contract management processes.

Competenze

• 5+ years in client service roles within biotech or pharma.
• Experience with Study Start-Up processes and contract management.

Mansioni

• Develop and negotiate site-specific clinical trial agreements.
• Track contractual negotiations and prepare status reports.
• Mentor junior staff and facilitate contract execution.

Conoscenze

Contract Negotiation

Project Management

Client Service

Mentoring

Formazione

B.A./B.S. in Business, Science, or Healthcare

Strumenti

Electronic Document Management Systems

Descrizione del lavoro

Job Description

Join a leading oncology-focused global pharmaceutical company. Under the guidance of the Manager, Site Contracts and Budgets, this position will be responsible for driving the tactical delivery of assigned studies or programs within the Global Clinical Study Support Department. The role involves participating in project teams to ensure timely contract and budget negotiations, adhering to applicable financial, contractual, and pharmaceutical R&D standards and regulations.

Duties and Responsibilities

• Develop site-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), or other related contractual documents.
• Negotiate contractual documents using established negotiation and escalation plans.
• Track the progress and status of contractual negotiations, preparing appropriate status reports.
• Facilitate the execution of contractual documents between investigators, sites, and clients.
• Mentor new or junior staff, providing project-specific training and addressing questions/issues.
• Collaborate with study teams to set up and maintain contract management systems that facilitate document creation, distribution, negotiation, and execution.
• Serve as the primary contact and escalation point for investigator sites, global negotiation network, or study team members during contractual negotiations.
• Assist in preparing performance metrics, such as median cycle times.
• Notify management of out-of-scope requests, timeline changes, or resource constraints.
• Perform other duties as assigned.

Requirements

• B.A./B.S., preferably in a business, science, healthcare, nursing, or equivalent field.
• At least five (5) years of experience in a client service role within a biotechnology or pharmaceutical company, CRO, or related organization supporting clinical research or healthcare activities.
• Experience with Study Start-Up processes at relevant organizations.
• Experience working with electronic document management systems or similar portals is desired.